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SEASPINE ORTHOPEDICS CORPORATION

10 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
SeaSpine Polyaxial Head REF Number: 41-3010 recall (Z-2762-2026)SEASPINE ORTHOPEDICS CORPORATION2026-07-20
Orthofix NorthStar OCT Navigation Surgical Technique Guide, and instruments: Navigation Dr recall (Z-0937-2026)SEASPINE ORTHOPEDICS CORPORATION2025-12-17
Reef TA Inserter, Part Number: TA2-001003, part of the Reef Interbody System recall (Z-2554-2025)SEASPINE ORTHOPEDICS CORPORATION2025-09-11
Brand Name: Daytona Small Stature Product Name: CoCr LockingCap 4.5mm, Small Stature, T25, recall (Z-0751-2025)SEASPINE ORTHOPEDICS CORPORATION2024-12-23
Brand Name: Daytona Small Stature Product Name: Ti Locking Cap 4.5mm, Small Stature, T25 M recall (Z-0752-2025)SEASPINE ORTHOPEDICS CORPORATION2024-12-23
Brand Name: Meridian Angled Awl Fixed Product Name: Angled Awl Fixed Model/Catalog Number: recall (Z-2357-2024)SEASPINE ORTHOPEDICS CORPORATION2024-07-15
Brand Name: Fathom Pedicle-Based Retractor Product Name: C/C Blade, 35-55mm Model/Catalog recall (Z-2234-2024)SEASPINE ORTHOPEDICS CORPORATION2024-06-28
Brand Name: Fathom Pedicle-Based Retractor Product Name: C/C Blade, 50-80mm Model/Catalog recall (Z-2235-2024)SEASPINE ORTHOPEDICS CORPORATION2024-06-28
Mariner RDX MIS Polyaxial Head, REF: MX1-001010, part of Mariner RDX MIS Alpha Instruments recall (Z-1620-2024)SEASPINE ORTHOPEDICS CORPORATION2024-04-23
Mariner RDX Polyaxial Head, REF: MX1-000020; Mariner RDX Extended Polyaxial Head, REF: MX1 recall (Z-1605-2024)SEASPINE ORTHOPEDICS CORPORATION2024-04-22

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Every clearance here is in the API, with alerts when new ones post.